Federal Joint Committee Supports Research Project
Rostock/Germany, February 2, 2022. A nationwide consortium in Germany led by DZNE has been tasked with investigating whether patients with “dementia of unclear etiology” benefit from examination of the brain using amyloid positron emission tomography (amyloid PET). The study – results are expected for 2026 – is commissioned and funded by the Federal Joint Committee (G-BA), which is the highest decision-making body of the joint self-government in the German healthcare system. In individuals with dementia of unclear etiology, the benefit of amyloid PET has not yet been sufficiently established, which is why such imaging examinations are generally not paid for by German health insurers. The study results are intended to enable the G-BA to decide on the benefit and necessity of such examinations – the verdict would have an impact on the benefits provided by the statutory health insurance.
In Germany, around 300,000 people develop dementia every year. According to estimates, for more than 100,000 of them, it remains unclear whether the underlying cause is the relatively common Alzheimer’s disease or another disease from the spectrum of dementias. In medical jargon, this is called “dementia of unclear etiology”. The current study aims to specify such indeterminate diagnoses in order to improve treatment and ultimately the quality of life of affected individuals. To this end, more than 1,100 patients with dementia of unclear etiology will be included in the study. In this context, the value of amyloid PET will be tested: This imaging method allows the detection of so-called amyloid plaques in the brain – these protein deposits are characteristic of Alzheimer’s disease.
A Nationwide Consortium
Under the leadership of DZNE, 24 study centers located at university hospitals as well as institutions from the certified private practice sector will participate across Germany. In addition, professional societies from the fields of neurology, nuclear medicine and radiology are involved in the scientific advisory board of the project; a technical advisory board and representatives from industry provide support for technical aspects.
“This research project is a coordinated action of numerous partners from science and care, with the objective of improving the treatment of patients with dementia. DZNE’s nationwide clinical network and our close cooperation with university hospitals play a central role in this. In addition, many other stakeholders are participating in this project, which is unique in Europe,” says Prof. Thomas Klockgether, Director of Clinical Research at DZNE.
Prof. Wolfgang Mohnike, Medical Director of DTZ Berlin, a certified medical care center specializing in nuclear medicine, adds: “This project has a long history, which led to an initial meeting between representatives of PET e.V., industry, the German Society of Nuclear Medicine e.V. and DZNE with the G-BA in April 2017.”
This research project is a coverage with evidence development study (“Erprobungsstudie”). The aim of such a study according to §137e of Book V of the German Social Code (SGB V) is to is to obtain evidence for the benefit of a new diagnostic or therapeutic method as basis for a decision on health care and reimbursement in Germany.
Measurement of Daily Living Skills
Enrollment of patients in the study is set to begin this summer. Participants will be randomly assigned to one of two groups: Individuals in one of the groups will be scanned with amyloid PET, while those in the other group will not. “This way, we want to determine whether a brain scan with amyloid PET leads to a more accurate diagnosis and whether the treatment measures that result from this cause the patients to do better in their daily lives than members of the control group. We will record daily living competence according to scientific criteria over a period of two years,” explains the study’s director Prof. Stefan Teipel, a dementia researcher at DZNE’s Rostock/Greifswald site and Head of the Section for Gerontopsychosomatics and Dementia at Rostock University Medical Center.
Is it Alzheimer‘s?
“In a dementia, therapy options are limited, but nevertheless, depending on the type of dementia, there are specific medical interventions that reflect the current state of the art. However, if the type of dementia remains unresolved, this means that these patients may not receive the best possible treatment,” Teipel says. “It is important for an accurate diagnosis to confirm or rule out Alzheimer’s disease. Generally, this is done with the help of various methodologies. In particular, these include memory tests, laboratory diagnostics and examinations of the brain by magnetic resonance imaging.”
Hallmark Amyloid
If these procedures do not provide clarity, analysis of the cerebrospinal fluid, also known as “liquor”, may be considered. "Thereby, levels of amyloid proteins are determined. In Alzheimer’s disease, these proteins accumulate in the brain, and their levels in the liquor are an indicator of what is happening in the brain,” Teipel says. “However, this intervention is relatively rarely done. Many patients are reluctant about it.”
Deposits are Tagged
A way of directly detecting accumulations of these proteins in the brain is amyloid PET, which is used in particular in the context of scientific studies and drug trials. For this purpose, the examined individuals are administered a radioactive substance – called “tracer” – which binds to the amyloid plaques and thereby labels them. The radiation emitted by the tracer molecules is then recorded by a scanner and visualized. By this means, the location and concentration of the deposited proteins are detected. “This is a very sensitive procedure. But what it can do in the specific case of individuals with unclear dementia remains to be seen. Studies from the U.S. suggest that the amyloid PET may be beneficial in this group of patients. We now aim to clarify the extent to which this applies under the conditions of German routine care,” says Prof. Bernd Joachim Krause, Director of the Clinic for Nuclear Medicine at Rostock University Medical Center and coordinator of the PET examinations in the study.
“The availability of sufficient capacity for the PET examinations in the study will be ensured by nuclear medicine centers at the university hospitals and the DZNE sites as well as by PET centers in private practices,” reports PD Dr. Konrad Mohnike, chairman of PET e.V., Association for the Promotion and Dissemination of Positron Emission Tomography (Verein zur Förderung und Verbreitung der Positronen-Emissions-Tomographie).